(247 days)
The ECG Mini System Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center provides the ECG data to the medical practitioner for evaluation.
The device has not been tested for and it is not intended for pediatric use.
The ECG Mini System Continuous ECG Monitor and Arrhythmia Detector ("ECG Mini") is a system that records ECG data and detects defined arrhythmias. It is comprised of a disposable 1-lead ECG Patch which includes a processing/transmitting module called a "Brain", and a cellular device (also called "Gateway"). The ECG Patch has 3 electrodes which are used to obtain a 1-lead ECG that is used for arrhythmia detection. The ECG Patch is placed on the upper left side of the chest according to the instructions and guidance in the Patient User Guide (UG-00105).
The ECG Mini system consists of following three components:
- . Patch: Disposable 1-lead Patch with ECG electrodes
- Brain: Reusable processing and transmitter device
- . Gateway Cellular Device: Communicates data to the Monitoring Center
The provided document describes the LifeWatch ECG Mini System Continuous ECG Monitor and Arrhythmia Detector. Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, it lists performance tests and the standards they comply with, which implies that compliance with these standards serves as the acceptance criteria.
| Performance Area | Acceptance Criteria (Implied by Compliance) | Reported Device Performance |
|---|---|---|
| ECG Performance | Compliance with ANSI/AAMI/IEC 60601-2-47: 2012 | "Was shown to comply" |
| Arrhythmia Detection | Compliance with ANSI/AAMI EC57: 2012 | "Was tested in accordance with" |
| Human Factors | Usability Validation per IEC 62366:2007 (Section 5.9) | "Conducted a Usability Validation Study... focused on the ability of a test population... to initiate the use... and to understand user feedback signals." |
| ECG Electrode Electrical Perf. | Compliance with ANSI/AAMI EC12:2000/(R)2010 (Part 4.2.2) | "Was tested in accordance with" |
| Alarms | Compliance with IEC 60601-1-8, ed. 2.1:2012 | "Conducted an assessment demonstrating compliance" |
| ICD Compatibility | Demonstrated compatibility with Implantable Cardioverter Defibrillators (ICDs) | "Had conducted testing to demonstrate compatibility" |
| Wireless Co-Existence | Assessment in accordance with FDA guidance "Radio Frequency Wireless Technology in Medical Devices" | "Assessed the ECG Mini for Wireless Coexistence" |
Specific performance metrics for arrhythmia detection (e.g., sensitivity, specificity for specific arrhythmias) are not provided in this summary, only that testing was done to the standard.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test sets in any of its performance studies.
Regarding data provenance:
- The overall device is for "patients who experience transient symptoms that may suggest cardiac arrhythmia."
- There's no mention of country of origin for any data, nor if studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts or their qualifications used to establish ground truth for any of the performance studies.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or suggest that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, nor does it provide an effect size for human readers with and without AI assistance. The device is an "algorithm only" type of detection system, and its output (recorded data and alarms) is provided to medical practitioners for evaluation, implying it's not designed for human-in-the-loop assistance in real-time interpretation against an initial human read.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was conducted. The "Arrhythmia Detection" testing, compliant with ANSI/AAMI EC57: 2012, is an assessment of the algorithm's performance in detecting various arrhythmias. While specific metrics are not provided in this summary, the standard itself pertains to "Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms," indicating an algorithm-only evaluation.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any of its studies. For arrhythmia detection studies (per ANSI/AAMI EC57), it is typically a meticulously adjudicated ECG dataset by multiple cardiologists or experts, but this is not confirmed in the text.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set of the arrhythmia detection algorithm.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.